Efficacy and Safety of TMZ Plus CDDP in the Patients With Recurrent Malignant Gliomas

Phase 2

• Conditions: Malignant Gliomas
• Interventions: Drug: TMZ; Drug: TMZ plus CDDP

• Registration Number: NCT01670890
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Temozolomide is the standard adjuvant chemotherapy of newly-diagnosis malignant gliomas.Cisplatin , a kind of chemotherapeutics, can enforce the anti-tumor effects of TMZ. Up to now, the prognosis of recurrent gliomas is very pessimistic and the standard treatment procedure has not been established yet.

The prospective,multicentre phase II clinical study is to evaluate the efficacy and safety of TMZ and CDDP in patients with recurrent malignant gliomas

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2012-08
• Study Start: 2012-08
• Study First Submitted: 2012-08-19
• Study First Submitted QC: 2012-08-21
• Last Update Submitted: 2012-08-21
• Study First Posted: 2012-08-22
• Last Update Posted: 2012-08-22
• Primary Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Written informed consent
• Age>=18 and <=70years old
• Histological diagnosis of malignant gliomas(WHO III or IV)
• The status of methylation of promotor of MGMT should be detected.
• The time to be enrolled should be more than 90 days after the irradiation.
• The patients with recurrent gliomas were treated with non-dose-dense TMZ therapy before enrollment.
• Performance status(Karnofsky index)>=60
• Life expectancy more than 3 months

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Exclusion Criteria

• Ages:< 18 years or > 70 years
• Abnormal function of liver or renal(value more than 1.5 fold normal upper limit )
• Blood routing: Hb < 100g/l， WBC < 4.0×109/l; PLT < 100×109/l
• Pregnant or lactating women
• Allergic to administered drugs
• Radiation treatment in the previous 90 days or stereotactic radiation surgery within 60 days before enrollment
• The patients with recurrent gliomas were treated with dose-dense TMZ therapy before enrollment.
• Life expectancy less than 3 months
• Participation in other clinical trials in the 90previous days before enrollment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMZ group	TMZ	patients were treated with TMZ alone
TMZ plus CDDP group	TMZ plus CDDP	patients were treated with TMZ plus CDDP

Primary Outcome Measures

Name	Time	Method
over all survival	1 year

Secondary Outcome Measures

Name	Time	Method
progression free survival	6 months

Trial Locations

Locations (3)

Tianjin medical university general university; 🇨🇳 Tianjin, Tianjin, China

Beijing Tiantan Hospital Affiliated to Capital Medial University; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China